This recall is a precautionary measure based on the company’s investigation of visible particulate matter found in a small number of COUMADIN FOR INJECTION unreleased samples. Bristol-Myers Squibb believes the safety risk to patients is low, and is further mitigated by the product’s prescribing information advising that intravenous drug products be inspected visually prior to administration.
Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization. Allergic reactions to the foreign material could also occur. To date, there have been no product complaints or adverse events reported to Bristol-Myers Squibb related to this issue.
COUMADIN FOR INJECTION was discontinued in early April 2014. The oral formulation, Coumadin tablets, is not impacted by this recall.
COUMADIN FOR INJECTION is a prescription medicine used to treat blood clots and to lower the chance of blood clots forming in the body. COUMADIN FOR INJECTION is typically administered in a hospital setting by health care professionals to patients not able to receive the oral formulation.
COUMADIN FOR INJECTION 5 mg single-use vials is packaged in cartons of six vials.
Bristol-Myers Squibb has issued recall communications to health care professionals and other customers involved and is arranging for return of all recalled products. Anyone that has COUMADIN FOR INJECTION which is being recalled should stop use and distribution and contact Bristol-Myers Squibb’s recall vendor, GENCO, at 1-855-838-5784 to arrange for return of remaining stock.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.